Turnover Package Coordinator - CQV/Validation Readiness

Pinnaql, Inc.; Wilson (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Turnover Package Coordinator / Documentation Engineer to serve as the primary interface among Construction, Vendors, Engineering, CQV, Validation, and QA to ensure turnover packages are complete and compliant.

The role ensures packages are technically sound, aligned with boundaries, and meet GDP, GMP, and validation requirements before IQ/Commissioning begins, enabling efficient startup.

Qualifications

• Experience supporting GxP-regulated pharmaceutical, biotech, or medical device projects
• Strong understanding of Commissioning, Qualification, Validation, and turnover documentation processes
• Experience reviewing vendor, construction, and engineering turnover documentation packages
• Ability to read and interpret P&IDs, isometrics, engineering drawings, and technical specifications
• Working knowledge of GDP, GMP, and documentation management practices
• Experience participating in system walkdowns, punch list management, and closeout activities
• Strong coordination and cross-functional communication skills
• Ability to manage multiple priorities in fast-paced project environments
• Proficiency with Microsoft Office applications and document management systems

Responsibilities

• Turnover Package Review & Compliance: review packages for completeness, verify against boundaries, support commissioning readiness, ensure GDP/GMP compliance, verify required documentation, structure electronic files, support standardization.
• Coordination & Interface Management: act as liaison between Construction, Vendors, Engineering, CQV, Validation, and QA; manage submission requirements and revision control; resolve deficiencies before turnover.
• Field & Technical Support: participate in system walkdowns; track punch lists; aid with closeout issues; ensure timely collection and reconciliation of as-built documentation.
• Tracking, Reporting & Closeout: maintain turnover trackers and status reports; monitor readiness and communicate risks; assist with closeout activities and final reconciliation.

Skills

GxP experience

Coordination

Cross-functional communication

Documentation review

Reading technical drawings

Tools

Microsoft Office

Document Management Systems

Job description

Validation & Engineering Group, Inc. is seeking a Turnover Package Coordinator / Documentation Engineer to serve as the primary interface among Construction, Vendors, Engineering, CQV, Validation, and QA to ensure turnover packages are complete and compliant.

The role ensures packages are technically sound, aligned with boundaries, and meet GDP, GMP, and validation requirements before IQ/Commissioning begins, enabling efficient startup.